Management Article

Minitab Inc.’s picture

By: Minitab Inc.

Process validation is vital to the success of companies that manufacture pharmaceutical drugs, vaccines, test kits, and a variety of other biological products for people and animals. According to FDA guidelines, process validation is “the collection and evaluation of data, from the process design state through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a quality product.”

Ryan E. Day’s picture

By: Ryan E. Day

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life science industry, like BBG, operate in a heavily regulated environment. This is the story of how one company delivers world-class products and stays on the right side of compliance while doing it.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies share a common need as a prerequisite to success: regulatory compliance.

Mike Richman’s picture

By: Mike Richman

Technological breakthroughs tend to change the way users perceive of a problem, offering a solution that, in retrospect, comes to seem obvious and apparent. So it is with the new FARO 8-Axis Quantum ScanArm and FaroArm.

Dan Jacob’s picture

By: Dan Jacob

What a difference a year and a half make. In mid-2017, LNS Research coined the term “Quality 4.0” and published definitive research on the topic. At that time, an early but large group of manufacturers started to make Quality 4.0 one of their top digital transformation initiatives. This continues to accelerate, and today large groups of manufacturers are investigating Quality 4.0 and deploying pilots. While some used that time to consider the implications of the definitive research, most are eager to forge ahead.

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William A. Levinson’s picture

By: William A. Levinson

Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an OHS management system.

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Tom van Laer’s picture

By: Tom van Laer

Whether you are booking a hotel room, choosing a restaurant, deciding on what movie to see, or buying any number of things, it is likely you have read online reviews before making your decision.

What makes a consumer review persuasive, though? No matter how short, it tells a story in much the same way as a novel does. Yet, like a journalism report, it starts with its takeaway rather than saving that to the end.

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Aytekin Tank’s picture

By: Aytekin Tank

In his book, The ONE Thing: The Surprisingly Simple Truth Behind Extraordinary Results (Bard Press, 2013), author Gary Keller reminds us that everyone has 24 hours in a day. So, why do some people earn more, achieve more, and get more done? They “go small.” 

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Mike Richman’s picture

By: Mike Richman

Leaders lead. Those two simple words conceal the complicated fact that being a change agent means confronting the failures of the past and confidently facing the promise of the future. Stories addressing these facts, along with hot takes on current news and a preview of an exciting upcoming webinar, composed this past week’s QDL. Here’s a closer look:

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Lolly Daskal’s picture

By: Lolly Daskal

Every company I speak at, every leader I coach, I see a constant pattern: Virtually everyone sees struggle as something negative.

At the heart of this perception, people get too caught up in the idea of struggle to consider what struggle at its core is all about. Most people cannot see themselves objectively, which leads them to fall into the gap of their own weaknesses and shortcomings.

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